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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02719210
Other study ID # ILBS-ALF-02
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2016
Est. completion date November 30, 2018

Study information

Verified date May 2018
Source Institute of Liver and Biliary Sciences, India
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

All the children with acute liver failure who are candidates for transplant but have constraints for transplant will be randomized either to receive standard medical therapy or high volume plasma exchange along with standard medical therapy with the aim to assess the effect of high volume plasma exchange on transplant free survival.


Recruitment information / eligibility

Status Completed
Enrollment 75
Est. completion date November 30, 2018
Est. primary completion date November 30, 2018
Accepts healthy volunteers No
Gender All
Age group 1 Year to 18 Years
Eligibility Inclusion Criteria:

- Children = 10kg with ALF with INR = 4 or INR = 3 with Hepatic Encephalopathy.

Exclusion Criteria:

1. Evidence of active infection (Age specific neutrophilic leucocytosis (ANC) and procalcitonin = 2 and/or focus of active infection

2. Refusal of consent or assent (annexure 3)

3. Liver resections with liver failure

4. Patients with clinical suspicion of irreversible brain injury

5. Patients with acute kidney injury

Study Design


Intervention

Biological:
High Volume Plasma Exchange

Drug:
Hypertonic 3% saline

Mannitol

Device:
Elective positive pressure ventilation


Locations

Country Name City State
India Institute of liver and Biliary Sciences New Delhi Delhi

Sponsors (1)

Lead Sponsor Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Primary Transplant free Survival. 7 days
Primary Transplant free survival 30 days
Secondary Survival after liver transplant with or without High Volume Plasma Exchange. 30 days post procedure
Secondary Incidence of organ dysfunction (other than liver and Central Nervous System). 30 days
Secondary Number of organs (other than liver and CNS) affected in children with organ dysfunction. 30 days
Secondary Incidence of High Volume Plasma Exchange related complications- Major/Minor. within 1 month
Secondary Change in hemodynamic parameters and Hepatic Encephalopathy (HE) before and after in the High Volume Plasma Exchange group. 0 day
Secondary Change in hemodynamic parameters and Hepatic Encephalopathy (HE) before and after in the High Volume Plasma Exchange group. 5 days
Secondary Change in Laboratory parameters - Bilirubin, INR and Ammonia in control group. 0 day
Secondary Change in Laboratory parameters - Bilirubin, INR and Ammonia- in control group. 5 day
Secondary Change in the levels of IL-6 and TNF alpha (Tumor Necrosis Factor) in HVPE arm from baseline till within 24-hours of the last session of High Volume Plasma Exchange. within 24-hours of the last session of High Volume Plasma Exchange
Secondary Change in the levels of IL-6 and TNF alpha (Tumor Necrosis Factor) in control arm from baseline till 5 days. 5 days
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